相关临床试验
3
0 进行中
药物批准
162
批准总数
监管机构
4
监管机构数
成立时间
N/A
已完成
3
100.0%
- Novartis Pharmaceuticals Corporation plans to lay off 322 employees from its East Hanover, New Jersey facility by October 2, 2026, according to a WARN notice filed with the state. - The law firm Strauss Borrelli PLLC has launched an investigation into whether Novartis violated the federal WARN Act by failing to provide adequate 60-day advance notice. - These layoffs follow earlier workforce reductions at the same facility, including 114 layoffs in March, 60 in April, and 76 in May of the same year. - Affected employees may be entitled to 60 days of severance pay and benefits if the company is found to have violated WARN Act notification requirements.
- Lupin Limited has received tentative FDA approval for its generic version of Siponimod tablets in 0.25 mg, 1 mg, and 2 mg strengths for treating relapsing forms of multiple sclerosis. - The generic formulation is bioequivalent to Novartis' Mayzent and will be manufactured at Lupin's Pithampur facility in India. - The reference drug Mayzent had estimated annual U.S. sales of $195 million according to IQVIA data from October 2025. - The approval covers treatment of clinically isolated syndrome, relapsing remitting disease, and active secondary progressive multiple sclerosis in adults.
- A phase Ib clinical trial demonstrated that adding investigational antibody ianalumab to ibrutinib therapy allowed 17 out of 39 chronic lymphocytic leukemia patients to discontinue daily treatment for 12-24 months. - The combination achieved a 60% overall response rate and 43.6% of patients reached undetectable measurable residual disease, indicating deep remissions that could enable treatment-free intervals. - The therapy showed a favorable safety profile with no dose-limiting toxicities and lower infection rates compared to single-agent ibrutinib, potentially transforming CLL from lifelong to fixed-duration treatment.
- Alembic Pharmaceuticals has received final USFDA approval for generic Carbamazepine 200 mg tablets, an anticonvulsant used for seizure disorders and neuropathic pain with a US market size of approximately $32 million. - The company also secured approval for Amlodipine-Atorvastatin combination tablets in multiple strengths, expanding its portfolio in the cardiovascular therapeutic area. - With these recent approvals, Alembic now holds a total of 223 ANDA approvals from the USFDA, strengthening its position in the US generics market across CNS and cardiovascular segments.
- The FDA has granted accelerated approval to asciminib (Scemblix) for adult patients with newly diagnosed Philadelphia chromosome-positive chronic myeloid leukemia (Ph+ CML). - Asciminib, a BCR::ABL1 kinase inhibitor, showed a major molecular response (MMR) rate of 68% at 48 weeks in the ASC4FIRST trial. - The ASC4FIRST trial demonstrated a statistically significant improvement in MMR compared to investigator-selected tyrosine kinase inhibitors (49%). - Common adverse reactions to asciminib included musculoskeletal pain, rash, fatigue, and upper respiratory tract infection.
- GSK has agreed to acquire Boston Pharmaceuticals' phase 3-ready liver disease candidate efimosfermin alfa for $1.2 billion upfront, with potential milestone payments bringing the total to $2 billion. - Efimosfermin, a once-monthly FGF21 analog therapeutic, has demonstrated significant ability to reverse liver fibrosis and halt disease progression in patients with moderate-to-advanced MASH in phase 2 trials. - The acquisition expands GSK's hepatology pipeline and offers potential combination therapy options with GSK's siRNA therapeutic GSK'990, targeting steatotic liver disease which affects approximately 5% of the global population.
